Kornimate/medical-research-clean huggingface dataset:
an italian multicenter retrospective observational study to assess effectiveness and safety of siltuximab for patients with castleman's disease treated in italy in a real-life context

Conditions: Castleman Disease

Summary: the study is a pilot, observational, retrospective, and (italian) multicenter study. the study will involve the collection of patient data from medical records for patients with multicentric castelman disease relapsed/refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from july 2016 till april 2022 in 31selected italian centres.

the aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (r/r) mcd in a real-life context since approval as more data are needed to improve knowledge in this rare disease. the observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of r/r mcd hiv and hhv-8 negative patients who underwent siltuximab in a real-life context from july 2016 till april 2022. 2. age ≥ 18 yearsatenrollment 3. signature of written informed consent (where applicable) exclusion criteria: 1. r/r mcd patients who underwent siltuximab in a clinical trial context

Keywords: siltuximab
emergency department management of sepsis patients: a goal-oriented non-invasive sepsis trial

Conditions: Sepsis; Shock, Septic

Summary: the purpose of this study is to determine whether the use of a 3-hour protocol utilizing non-invasive hemodynamic optimization treatment strategy results in better outcome and lower hospital costs in patients who present with severe bloodstream infections to the emergency department (ed).

severe sepsis is a syndrome where the body develops organ dysfunction secondary to uncontrolled inflammatory response to infection. various resuscitation bundles have been formulated and practised to treat severe sepsis, such as early goal-directed therapy (egdt). egdt involves the insertion of invasive catheters in patients with severe sepsis or septic shock using serial measurements to guide therapy and achieve hemodynamic goals, such as mean arterial pressure (map), central venous pressure (cvp) and central venous oxygen saturation (scvo2) by 6 hours. the drawbacks include the invasive nature of inserting these catheters with its complications and tedium to set up the equipment. a non-invasive approach using the non-invasive cardiac output monitor (nicom) and passive leg raising (plr) maneuver to guide fluid and vasoactive agent therapy targeting fluid responsiveness and map may be able to achieve better outcome, measured by lactate clearance at 3 hours and at a lower hospitalization cost.

Eligibility criteria:
inclusion criteria: * fulfillment of at least 2 systemic inflammatory response syndrome (sirs) criteria * suspected infection * serum lactate ≥3mmol/l exclusion criteria: * age below 21 years * known pregnancy * prisoners * do-not-attempt resuscitation status * known severe aortic insufficiency or severe anatomic abnormalities of the thoracic aorta * primary diagnosis of trauma, burns, active seizures, acute cerebral vascular accident, acute coronary syndrome, status asthmaticus, major cardiac arrhythmias, active gastrointestinal haemorrhage, seizure or drug overdose * requirement for immediate surgery * inability to do plr (e.g. ankylosis of hip joint, severe sciatica) * treating physician deems aggressive care unsuitable * those unable to give informed consent and unable to comply with study requirements

Keywords: sepsis emergency medicine cardiac output stroke volume lactate
the effects of dietary factors on physiological subjective stress responses

Conditions: Chronic Stress

Summary: the study aims to investigate the role of dietary factors in chronically stressed subjects. previous studies have shown that milk proteins, b vitamins and probiotics may influence on subjective well-being in stressed subjects.


Eligibility criteria:
inclusion criteria: * stai points 40-65 * bmi 18-30 kg/m2 * healthy exclusion criteria: * gastrointestinal disease, diabetes or any other significant major medical morbidity * milk allergy * smoking * excess use of alcohol * pregnancy and breast feeding * waist circumference males \>102 cm, females \>88 cm * no medication or dietary supplements influencing measured responses

Keywords: milk protein probiotics stress cortisol heart beat
eset plus single embryo cryotransfer vs double embryo transfer

Conditions: Infertility; Pregnancy, Multiple

Summary: the purpose of this study is to determine whether a policy of elective single embryo transfer (eset) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

the objective is to evaluate the in vitro fertilization/intracytoplasmic sperm inyection (ivf/icsi) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer. this is a prospective randomized study, including couples arriving to the reproductive unit of the hospital universitario virgen de las nieves. all these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: group 1: elective single embryo transfer. in the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. group 2: elective double embryo transfer.

Eligibility criteria:
inclusion criteria: * women less tan 38 years * women body mass index (bmi) between 19-39 kg/m2 * follicle-stimulating hormone (fsh) \<15 mui/ml on cycle third day * first ivf/icsi cycle or second after a positive pregnancy test in the first one exclusion criteria: * more tan five years of infertility * previous uterus surgery * uterus malformations * more tan one miscarriage
ambulatory oxygen effects on muscles in copd

Conditions: COPD

Summary: patients with chronic obstructive pulmonary disease (copd) may develop low oxygen levels, because of damage to their lungs. long term oxygen therapy (ltot) is given for at least 15 hours per day, and has established indications and benefits in copd. however, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. this is a pilot study of supplementary ambulatory oxygen in copd, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * desaturation on exertion exclusion criteria: * using ltot * immobile for other reason than copd
a study comparing perioperative stress reduction vs. standard of care in ovarian cancer (preserve)

Conditions: Ovarian Cancer; Ovarian Carcinoma; Stage II Ovary Cancer; Stage II Ovarian Cancer; Stage III Ovary Cancer; Stage III Ovarian Cancer; Stage IV Ovary Cancer; Stage IV Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Stage II Fallopian Tube Cancer; Stage III Fallopian Tube Cancer; Stage IV Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/mbrt and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/pds or ids and also if it's better than the standard-of-care approach (no intervention for reducing stress).


Eligibility criteria:
inclusion criteria: * advanced (stage ii-iv) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, ca125, and clinical assessment * scheduled to undergo exploratory laparotomy and pds or ids * scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and cox2 inhibitor 7 days preoperatively * age ≥18 years * asa score of 1 to 3 * ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent exclusion criteria: * chronic treatment with any β-blocker or cox inhibitor * contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease) * contraindication for cox2 inhibitor therapy (renal failure \[creatinine level \>1.5 mg/dl\], significant liver failure \[known cirrhosis, bilirubin level \>2\], active peptic disease), or current use of oral anticoagulant) * contraindication for regional epidural anesthesia * chronic autoimmune disease * active infection * pregnant * minimally invasive procedure * participation in another clinical trial that interferes with this study

Keywords: ovarian cancer propranolol etodolac mbrt mind-body resilience training music therapy epithelial ovarian cancer fallopian tube cancer primary peritoneal carcinoma
tramadol hydrochloride and dexketoprofen trometamol for the oral treatment of moderate to severe acute pain following removal of impacted lower third molar

Conditions: Acute Pain

Summary: the study is aimed to evaluate the analgesic efficacy of tram.hcl/dkp.tris 75mg/25mg oral fixed drug combination in comparison with tram.hcl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

the present phase iv study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar. in this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio: * tram.hcl/dkp.tris * paracetamol/tram.hcl * placebo.

Eligibility criteria:
inclusion criteria: * male or female patients aged more than 18 years. females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate. * scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation. * pain of at least moderate intensity in the first 4 hours after the end of surgery (nrs score ≥ 4). exclusion criteria: * history of allergy or hypersensitivity to the study treatments, rm or to any other nsaids, opioids and acetyl salicylic acid. * history of peptic ulcer, gastrointestinal disorders by nsaids or gastrointestinal bleeding or other active bleedings. * history of any illness or condition that, in the opinion of the investigator might pose a risk to the patient or confound the efficacy and safety results of the study. * patients using and not suitable for withdrawing the prohibited medications specified in the protocol.

Keywords: acute pain acute moderate to severe pain postoperative pain dexketoprofen tramadol dexketoprofen trometamol tramadol hydrochloride multimodal analgesia third molar extraction fixed drug combination paracetamol analgesics
buried intramedullary k-wire fixation compared with plate and screw fixation for metacarpal fractures in unstable extra-articular metacarpal fractures

Conditions: Metacarpal Fracture

Summary: randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.

metacarpal fractures are a common injury to the hand. most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation. the purpose of this study is to compare plate and screw and buried intramedullary fixation, using the disabilities of the arm, shoulder, and hand (dash) questionnaire as the primary outcome measured. secondary outcomes will include total active motion, complications, cost, reoperation rate.

Eligibility criteria:
inclusion criteria: * the patient has an unstable extra-articular metacarpal fracture that meets operative indications * informed consent is obtained from the patient or proxy * male or female who are 16 years of age or older exclusion criteria: * if the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.) * pathological fracture * greater than 21 days from fracture to definitive open reduction and internal fixation * if contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation * highly comminuted diaphyseal fractures * articular fractures * multiple fractures involving bones other than another metacarpal in the same upper extremity * the patient had a previous upper extremity injury that has limited hand function or finger range of motion
phase 2 study of sorafenib plus haic of folfox vs. sorafenib plus haic of oxa for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) of oxaliplatin plus fluorouracil/leucovorin compared with haic of oxaliplatin alone in patients with advanced hepatocellular carcinoma (hcc)

sorafenib is the most widely used palliative treatment for advanced hepatocellular carcinoma (hcc) patients . our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (haic) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to advanced hcc . however, haic of fluorouracil is not such for advanced hcc. whether haic of oxaliplatin is as effective as haic of oxaliplatin plus fluorouracil/leucovorin is controversial. thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: platelet count ≥ 75,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * serious non-healing wound, ulcer, or bone fracture * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma sorafenib hepatic artery infusion chemotherapy oxaliplatin, 5-fluorouracil and leucovorin oxaliplatin
beverage choice and lifestyle modification in overweight youth

Conditions: Obesity

Summary: the rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. this research study developed and tested a "beverage choice and lifestyle modification" (bclm) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. the overall study objectives were to test the acceptability and effectiveness of the bclm intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and bmi group. the investigators hypothesized that those children randomized to the bclm group will show greater improvements in weight and body mass index (bmi) status, beverage choices,and energy intake than those assigned to our nutrition education (ne) group.


Eligibility criteria:
inclusion criteria: * ages 4-8 years old * bmi≥85th percentile (based on age and sex) * consumes large (≥16 oz.day) sugar sweetened beverages exclusion criteria: * child has a serious medical condition * signs of elevated psychopathology are present, as assessed by the child behavior checklist (cbcl) * parent demonstrates elevated psychiatric problems or eating disorders * failure of parent or child to meet bmi criteria

Keywords: pediatric obesity child overweight
a multicentre prospective study evaluating an off-loading mattress overlay system in healing of stage 3 pressure ulcers

Conditions: Pressure Ulcer

Summary: this study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. the overlay is placed over the patient's bed making it easier for patients to get in and out of bed. in addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.

the study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. after screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. the mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (snf). patients responding to the offloading regimen (percent wound area reduction \>20% at 4 weeks) may use the overlay for up to 12 additional weeks. the soc in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.

Eligibility criteria:
inclusion criteria 1. subjects are male or female, 18 years of age or older. 2. pressure ulcer/injury present for greater than 4 weeks (documented in the medical record). 3. subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. objectively, less than 20% healing in the past four weeks from the first treatment visit. 4. study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit. 5. the subject is able and willing to follow the protocol requirements. 6. subject has signed informed consent. exclusion criteria 1. subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia. 2. subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound. 3. the subject has other concurrent conditions that, in the opinion of the investigator, may compromise subject safety. 4. concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. 5. subject is pregnant or breast feeding. 6. subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. 7. index ulcer has been previously treated with tissue engineered materials (e.g. apligraf® or dermagraft®) or other scaffold materials (e.g. oasis, matristem) within the l 30 days preceding the first treatment visit. 8. affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1. 9. known hba1c \>12%. 10. mini-nutritional assessment malnutrition indication score \<17.
inflammation and the heart

Conditions: Rheumatoid Arthritis

Summary: studies have shown that people with rheumatoid arthritis (ra) have a higher rate of heart disease than people that do not have ra. we believe this is caused by the inflammation produced by ra.

aim 1: we want to study people with ra to see if we can detect very early changes in their heart muscle and compare these results to people who do not have ra.

Eligibility criteria:
inclusion criteria: * written informed consent * age \>= 18 * ra only: meet american college of rheumatology(acr)criteria for diagnosis of ra * controls only: no evidence of ra or other inflammatory disease exclusion criteria: * previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, cabg, stent). * atrial fibrillation. * known structural or functional cardiac abnormality, including pulmonary htn. * glomerular filtration rate \< 60 ml/min. * pregnancy or breastfeeding. * unable to perform mri (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-mr safe implant). * hypersensitivity to gadolinium.

Keywords: rheumatoid arthritis inflammation